Chugai’s Hemlibra Receives Approval for Severe Hemophilia A Without Factor VIII Inhibitors from the European Commission

14.3.2019 06:00:00 CET | Business Wire

Del

Chugai
Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that Roche
received the decision from the European Commission confirming that
Hemlibra® (emicizumab) , a hemophilia A treatment originated
by Chugai, has EU marketing authorization for routine prophylaxis of
bleeding episodes in adults and children with severe hemophilia A
(congenital factor VIII deficiency, FVIII <1%) without factor VIII
inhibitors. The EU Commission also approved that Hemlibra can be used
with multiple dosing options (once weekly, every two weeks, or every
four weeks) for all indicated people with hemophilia A, including those
with factor VIII inhibitors.

“We are very thrilled that people with severe hemophilia A without
inhibitors in the EU can be offered Hemlibra with multiple dosing
options,” said Chugai’s President & CEO, Tatsuro Kosaka. “In addition to
its efficacy, the availability of subcutaneous injection has been well
accepted especially among children. This approval enables flexibility in
Hemlibra’s dosing schedule that may better fit into the life of each
person with hemophilia A regardless of their inhibitor status. We truly
hope that Hemlibra will be widely recognized as a treatment option for
hemophilia A, and bring benefits to people with hemophilia A and their
caregivers in Europe.”

This approval is based on the results from two Phase III studies HAVEN 3
(NCT02847637) and HAVEN 4 (NCT03020160), conducted jointly with Roche
and Genentech. HAVEN 3 study was conducted to evaluate the reduction of
bleed rate of Hemlibra subcutaneous injection once a week and once every
two weeks in people with hemophilia A (12 years of age or older) without
inhibitors to factor VIII. HAVEN 4 study was conducted to evaluate
efficacy, safety, and pharmacokinetics of Hemlibra subcutaneous
injection every four weeks in people with hemophilia A (12 years of age
or older), with and without inhibitors to factor VIII.

In Japan, Chugai obtained regulatory approval for Hemlibra from the
Ministry of Health, Labour and Welfare in December 2018 for an
additional indication of prophylactic treatment for people with
hemophilia A without inhibitors to factor VIII, as well as for
additional dosage and administration as a biweekly or every four-week
treatment for people with hemophilia A with inhibitors to factor VIII.

People with severe hemophilia A is defined as the condition with less
than 1% of factor VIII levels1. Approximately 50-60% of
people with hemophilia A worldwide are expected to have a severe form of
the disorder2.

About Chugai

Chugai Pharmaceutical is one of Japan’s leading research-based
pharmaceutical companies with strengths in biotechnology products.
Chugai, based in Tokyo, specializes in prescription pharmaceuticals and
is listed on the 1st section of the Tokyo Stock Exchange. As an
important member of the Roche Group, Chugai is actively involved in R&D
activities in Japan and abroad. Specifically, Chugai is working to
develop innovative products which may satisfy the unmet medical needs,
mainly focusing on the oncology area.
Additional information is
available on the internet at https://www.chugai-pharm.co.jp/english.